Methods

ELECT consisted of 16-wk DB, 32-wk initial open-label, and long-term phases. Adults with histopathologically confirmed NET or NET of unknown location with liver metastases and history of CS (diarrhea and/or flushing) with/without prior somatostatin analog (SSA) use who provided informed consent were randomized to LAN 120 mg or PBO every 4 wks. Patients could administer short-acting OCT if needed and were instructed to record daily the frequency and severity of symptoms in a diary using Interactive Voice (Web) Response System for 1 month pre-randomization and throughout the DB phase. Analysis of covariance (ANCOVA) models were used for these analyses with baseline symptoms, prior SSA, and country as factors. Given the high variability of urinary 5-hydroxyindoleacetic acid (5HIAA), values were log transformed.

Conclusions

The observed improvement in patient-reported symptoms supports the efficacy of LAN in CS. These findings are in concert with the previously reported primary result of less rescue medication use with LAN vs PBO.